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Orthopedic Implant

Ankle Implant for Arthritis

N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient is > 18 years of age
The patient is skeletally mature
Must not have
The patient has ankle arthrodesis with malleolar exeresis, severe neurological or vascular disease, loss of musculature or neuromuscular compromise, severe instability, maltracking or misalignment of the tibia and talus uncorrectable by surgery compromising the affected limb
The patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, Charcot's disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Summary

This trial is testing the success of a new ankle implant. It will look at things like pain and function, quality of life, and how long the implant lasts.

Who is the study for?
This trial is for adults over 18 with arthritis (degenerative, rheumatoid, or post-traumatic) who need ankle replacement surgery. They must be able to consent and follow the study's procedures. Excluded are prisoners, those mentally unable to participate, non-compliant individuals, pregnant women, patients with infections or poor bone quality, and those with severe limb issues.Check my eligibility
What is being tested?
The Zimmer Trabecular Metal Total Ankle System is being tested in people needing ankle replacements due to arthritis. The study aims to track how well the implant works by looking at pain relief, improved function, life quality measures and checking x-rays for durability.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include pain at the implant site, swelling of the affected limb(s), infection risks around the new joint and possible allergic reactions if sensitive to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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My bones have stopped growing.
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I am eligible for an ankle replacement due to arthritis or injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe ankle issues or nerve/blood vessel diseases affecting my leg.
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My bones are too weak or damaged to support surgical implants.
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I have had an infection in my joint before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survivorship
Secondary outcome measures
American Orthopaedic Foot and Ankle Society Score

Trial Design

1Treatment groups
Experimental Treatment
Group I: Zimmer TM Total Ankle SystemExperimental Treatment1 Intervention
Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Zimmer Trabecular Metal Total Ankle implant, like other joint replacement therapies, works by providing structural support and facilitating joint function. These implants replace damaged joint surfaces with metal and plastic components, which help to restore mobility and reduce pain. The metal components offer durability and stability, while the plastic parts mimic the cushioning effect of cartilage. This is crucial for arthritis patients as it directly addresses joint degradation, alleviates pain, and improves overall joint function, thereby enhancing the patient's quality of life.
Joint damage in rheumatoid arthritis: radiological assessments and the effects of anti-rheumatic drugs.Current evidence for a strategic approach to the management of rheumatoid arthritis with disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis.Occupational therapy for rheumatoid arthritis.

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,077 Total Patients Enrolled
62 Trials studying Arthritis
13,567 Patients Enrolled for Arthritis
Kacy Arnold, RN MBAStudy DirectorZimmer Biomet
7 Previous Clinical Trials
744 Total Patients Enrolled
3 Trials studying Arthritis
700 Patients Enrolled for Arthritis
Erin Osborn, MBAStudy DirectorZimmer Biomet

Media Library

Zimmer Trabecular Metal Total Ankle System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT02038140 — N/A
Arthritis Research Study Groups: Zimmer TM Total Ankle System
Arthritis Clinical Trial 2023: Zimmer Trabecular Metal Total Ankle System Highlights & Side Effects. Trial Name: NCT02038140 — N/A
Zimmer Trabecular Metal Total Ankle System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02038140 — N/A
~24 spots leftby Mar 2027